CICATRISAN Cream

Manufacturer
Seroyal USA | SAN'UP
Effective date
2021-07-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:14:40

Label at a glance#

ProductCICATRISAN Cream
Active ingredientBALSAM PERU, BRYONIA DIOICA ROOT, SOLANUM DULCAMARA TOP, CALENDULA OFFICINALIS FLOWERING TOP, PHYTOLACCA AMERICANA ROOT
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
This preparation contains:
Balsamum peruvianum
(Peruvian balsam) Balsam MT 1.0%
Bryonia dioica (Red bryony)
Root MT 1.0%
Calendula officinalis
(Marigold) Aerial Parts MT 1.0%
Dulcamara (Bittersweet)
Shoots MT 1.0%
Phytolacca decandra
(Pokeweed) Root MT 1.0%

OTC - PURPOSE SECTION

Uses
For the temporary relief of symptoms
associated with minor skin irritations.

WARNINGS SECTION

Warnings
For external use only.
Stop use and ask a doctor if symptoms
persist or worsen.
If pregnant or breastfeeding, ask a
health professional before use. Keep out
of reach of children. If swallowed, get
medical help or contact a Poison Control
Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

If swallowed, get medical help or contact a Poison
Control Center right away.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Boric acid, mineral oil, sorbitan
sesquioleate, white petrolatum

DOSAGE & ADMINISTRATION SECTION

Directions
Adults: Apply a small amount on the
affected area two to three times daily, or as
recommended by your healthcare
practitioner. May cover affected area with
sterile gauze after each application.
Children: Use under the direction of your
healthcare practitioner.

INDICATIONS & USAGE SECTION

Uses
For the temporary relief of symptoms
associated with minor skin irritations.

Directions
Adults: Apply a small amount on the
affected area two to three times daily, or as
recommended by your healthcare
practitioner. May cover affected area with
sterile gauze after each application.
Children: Use under the direction of your
healthcare practitioner.

OTHER SAFETY INFORMATION

Other information
Do not use if inner seal is missing or
broken.
Store in a cool, dry place.

Contents may not fill package in order to
accommodate required labeling. Please
rely on stated quantity

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62106-3152-062106-3152-0

NDC 62106-3152-0

UNDA topicals

CICATRISAN CREAM

Homeopathic Preparation

For the temporary relief of symptoms
associated with minor skin irritations.

Net Weight 1.4 oz. (40 g)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-3152-0CICATRISAN Cream1 in 1 CARTONCREAM14
62106-3152-0CICATRISAN Cream40 g in 1 TUBECREAM404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-3152CICATRISAN CREAM (CALENDULA OFFICINALIS, PHYTOLACCA DECANDRA, BRYONIA DIOICA, BALSAMUM PERUVIANUM, DULCAMARA) CREAM [SEROYAL USA]4Current NDC, Legacy NDC, 2 package rows20210715_156ec27b-d27e-1739-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BALSAM PERUACTIVE INGREDIENT8P5F881OCY1
BRYONIA DIOICA ROOTACTIVE INGREDIENT53UB5FH7CX1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ1
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEG1
SOLANUM DULCAMARA TOPACTIVE INGREDIENTKPS1B1162N1
BALSAM PERUACTIVE MOIETY8P5F881OCY1
BRYONIA DIOICA ROOTACTIVE MOIETY53UB5FH7CX1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ1
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEG1
SOLANUM DULCAMARA TOPACTIVE MOIETYKPS1B1162N1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D41
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5A1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62106-315262106-3152-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BORIC ACIDBORIC ACIDR57ZHV85D4SHAMPOO / TOPICAL2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii+route
6 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SHAMPOO / TOPICAL2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4EMULSION / TOPICAL1.3 %w/wExact identifier — unii+route
6 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4EMULSION / TOPICAL1.3 %w/wExact identifier — unii+route
6 equally ranked IID candidates
SORBITAN SESQUIOLEATESORBITAN SESQUIOLEATE0W8RRI5W5AOINTMENT / TOPICAL75 mgExact identifier — unii+route
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii+route
6 equally ranked IID candidates
SORBITAN SESQUIOLEATESORBITAN SESQUIOLEATE0W8RRI5W5AOINTMENT / TOPICAL75 mgExact identifier — unii+route
2 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CICATRISAN CreamCALENDULA OFFICINALIS, PHYTOLACCA DECANDRA, BRYONIA DIOICA, BALSAMUM PERUVIANUM, DULCAMARASeroyal USA156ec27b-d27e-1739-e054-00144ff88e882021-07-14WarningsExact identifier
ndc (package): 62106-3152-0
ndc (product): 62106-3152
ndc11 (package): 62106315200
spl id: c71eb176-d09b-45b3-e053-2a95a90a53df
spl set id: 156ec27b-d27e-1739-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.